Medical device

ABSTRACT

A medical device includes a treatment module configured to apply a treatment to a patient. The medical device includes an interface configured to operatively connect to a removable storage device storing authorization data that identifies a level of treatment authorization. The medical device includes a processing device configured to perform operations in response to receiving user input indicating a treatment should be initiated. The operations include determining whether the removable storage device is valid for use with the medical device. If the removable storage device is determined to be valid, the authorization data is accessed. The processing device determines whether the treatment is authorized based on the accessed authorization data. If the treatment is determined to be authorized, the treatment module is controlled to apply the treatment. If the treatment is determined to not be authorized, the treatment module is controlled such that the treatment is not applied.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/271,870, field on Oct. 12, 2011, and titled “Medical Device,” whichclaims priority to and the full benefit of U.S. Provisional ApplicationSer. No. 61/392,154, filed Oct. 12, 2010, and titled “Authorizing Use ofMedical Devices,” U.S. Provisional Application Ser. No. 61/405,405,filed 5 Oct. 21, 2010, and titled “Medical Device,” U.S. ProvisionalApplication Ser. No. 61/405,757, filed Oct. 22, 2010, and titled“Medical Device,” and U.S. Provisional Application Ser. No. 61/483,445,filed May 6, 2011, and titled “Medical Device,” the entire contents ofwhich are incorporated herein by reference.

FIELD

This description relates to a medical device.

BACKGROUND

Medical devices can provide treatment for a variety of healthconditions. In some instances, a patient has a degree of control overtreatment with a medical device. For example, a patient may be able toinitiate treatment with a medical device. The capabilities of a medicaldevice determine to a large degree the way that the patient and othersinteract with the medical device. In particular, it is important that amedical device be capable of providing effective treatment and apositive patient experience.

SUMMARY

In one aspect, a medical device includes: a treatment module configuredto apply a treatment to a patient; one or more processing devicesconfigured to: disallow treatment using the treatment module untiltreatment authorization occurs; determine that treatment authorizationoccurs; and in response to determining that treatment authorizationoccurs, permit treatment to be applied using the treatment module.

Implementations may include one or more of the following features. Forexample, treatment authorization occurs via payment. Treatmentauthorization occurs via patient identification. Treatment authorizationis linked to geographic location. Treatment authorization occurs viaauthorization data stored on a removable medium.

In another general aspect, a medical device includes: at least onetreatment module configured to apply a treatment to a patient; aninterface configured to operatively connect to a removable storagedevice storing authorization data that identifies a level of treatmentauthorization; and at least one processing device configured to performthe following in response to receiving user input indicating a treatmentshould be initiated: determine whether the removable storage device isvalid for use with the medical device; if the removable storage deviceis determined to be valid, access the authorization data; determinewhether the treatment is authorized based on the accessed authorizationdata; if the treatment is determined to be authorized, control thetreatment module to apply the treatment; and if the treatment isdetermined to not be authorized, control the treatment module such thatthe treatment is not applied.

Implementations of any of the aspects may include one or more of thefollowing features. For example, to determine whether the removablestorage device is valid for use with the medical device, the at leastone processing device is configured to: access a serial number of theremovable medium; and determine that the removable medium is valid ifthe serial number is within a predetermined range of values. The atleast one processing device is configured to record compliance data forthe treatment on the removable storage device if the treatment isapplied. The compliance data indicates a time, date, and duration of thetreatment. The treatment module includes at least one ultrasoundtransducer and at least one driver circuit coupled to the ultrasoundtransducer. To control the treatment module to apply the treatment, theprocessing device is configured to control the driver circuit such thatthe driver circuit causes the ultrasound transducer to produceultrasound with therapeutic properties. To control the treatment modulesuch that the treatment is not applied, the processing device isconfigured to control the driver circuit such that ultrasound withtherapeutic properties is not produced. The driver circuitry includes asignal generator and an ultrasound transducer driver.

The authorization data indicates a number of authorized treatments, andthe at least one processing device is configured to decrease the numberof authorized treatments indicated by the authorization data after atreatment is applied. The authorization data indicates an authorizedamount of treatment time, and the at least one processing device isconfigured to decrease the amount of authorized treatment time indicatedby the authorization data after a treatment is applied. The medicaldevice includes a communication module. The at least one processingdevice is configured to: receive authorization data that indicates alevel of treatment authorization through the communication module; storethe received authorization data on the removable storage device or asecond storage device of the medical device; and in response toreceiving the user input indicating a treatment should be initiated,determine whether the treatment is authorized based on the receivedauthorization data. The communication module is a wireless communicationmodule. The wireless communication module is a cellular communicationmodule.

The authorization data is received from a server system configured to:determine that payment has been made for a number of treatments;determine that the payment is associated with the medical device;generate the authorization data; and transmit the authorization data tothe medical device. The processing device is further configured toprovide, if the treatment is determined to not be authorized, anindication to the patient that more treatments need to be purchased. Theprocessing device is configured to receive new authorization data afterproviding the indication to the patient that more treatments need to bepurchased, the new authorization data identifying a number of additionaltreatments for which payment has been received. The authorization datais encrypted, and the processing device is further configured to decryptthe authorization data. The medical device includes a second storagedevice. The second storage device stores a device identifier thatuniquely identifies the medical device, the authorization data isencrypted, the at least one processing device is further configured todecrypt the authorization data; and the device identifier is used todecrypt the authorization data. The medical device includes a paymentmodule configured to receive payment for a number of treatments. Thepayment module is configured to receive payment through a code, a creditcard, or a SIM card. The at least one processing device is configuredto: record on the removable storage device or an internal storage deviceinformation indicating occurrences of treatment applied by the medicaldevice; and indicate, on a display of the medical device, days duringwhich treatment was applied and days during which treatment was notapplied. The medical device stores information about a treatment regimenfor use of the medical device; and the at least one processing device isconfigured to indicate compliance with the treatment regimen bydisplaying a calendar that indicates the days during which treatment wasapplied and the days during which treatment was not applied.

In another general aspect, a medical device includes: a treatment moduleconfigured to apply a treatment to a patient, the treatment moduleincluding at least one ultrasound transducer and at least one drivercircuit coupled to the ultrasound transducer, a display, one or moredata storage devices, and one or more processing devices. The one ormore processing devices are configured to: receive user input that atreatment should be initiated using the treatment module; in response toreceiving the user input, apply a treatment using the treatment module;record on the one or more data storage devices information indicatingoccurrences of treatment using the treatment module; and indicate on thedisplay days during which treatment was applied and days during whichtreatment was not applied.

Implementations of any of the aspects may include one or more of thefollowing features. For example, the days during which treatment wasapplied and days during which treatment was not applied are indicated ona calendar. Days of the calendar during which one or more treatments areapplied are marked with a check mark and days of the calendar duringwhich one or more treatments were not applied are unchecked. The one ormore storage devices store information about a treatment regimen for useof the medical device, and the one or more processing devices areconfigured to indicate compliance with the treatment regimen on thecalendar. The one or more processing devices being configured toindicate on the display days during which treatment was applied and daysin which treatment was not applied includes the one or more processingdevices being configured to automatically indicate on the display, inresponse to the medical device being powered on, days during whichtreatment was applied and days during which treatment was not applied.

The medical device includes means for determining the geographiclocation of the medical device, and treatment is not allowed to commenceif the determined geographic location is outside an authorizedgeographic location. The medical device includes means for determininguser identity, and treatment is not allowed to commence if thedetermined user identity does not match an authorized identity. Thetreatment module is configured to produce a pulsed ultrasound signalhaving a frequency in the range of 1 MHz to 2 MHz, consisting of pulsesgenerated at a rate in the range of 100 Hz to 10 KHz with each pulsehaving a duration in the range of 10 microseconds to 2,000 microseconds.The pulsed ultrasound signal has a power intensity of 100 milliwatts persquare centimeter or less. The medical device is a hand-held deviceconfigured to accelerate bone healing.

In another general aspect a computer-implemented method includes:receiving user input through a user interface of a medical device, theuser input indicating a treatment should be administered by the medicaldevice, and the medical device includes a treatment module configured toapply a treatment to a patient; determining whether a removable storagedevice coupled to the medical device is valid for use with the medicaldevice; in response to determining that the removable storage device isvalid for use with the medical device, accessing authorization datastored on the removable storage device; determining that the treatmentis authorized based on the accessed authorization data; and controllingthe treatment module to apply the treatment in response to determiningthat the treatment is authorized based on the accessed authorizationdata.

Implementations of any of the aspects may include one or more of thefollowing features. For example, determining whether the removablestorage device coupled to the medical device is valid for use with themedical device includes accessing a serial number of the removablemedium and determining that the removable medium is valid if the serialnumber is within a predetermined range of values. Recording compliancedata for the treatment on the removable storage device if the treatmentis applied. The treatment module includes at least one ultrasoundtransducer and at least one driver circuit. Controlling the treatmentmodule to apply the treatment includes controlling the driver circuitsuch that the driver circuit causes an ultrasound transducer to produceultrasound with therapeutic properties. Controlling the treatment modulesuch that the treatment is not applied includes controlling the drivercircuit such that ultrasound with therapeutic properties is notproduced. Receiving the authorization data, and storing the receivedauthorization data on the removable device.

Receiving the authorization data includes receiving the authorizationdata with a wireless communication module. The wireless communicationmodule is a cellular communication module. The authorization dataindicates a number of authorized treatments, and thecomputer-implemented method further includes decreasing the number ofauthorized treatments indicated by the authorization data after atreatment is applied. The authorization data indicates an authorizedamount of treatment time, and the computer-implemented method furtherincludes decreasing the amount of authorized treatment time indicated bythe authorization data after a treatment is applied. Storing a deviceidentifier that uniquely identifies a medical device. The authorizationdata is encrypted, accessing the authorization code includes decryptingthe authorization data, and the device identifier is used to decrypt theauthorization data. Recording on the removable storage device or aninternal storage device information indicating occurrences of treatmentapplied by the medical device. Indicating, on a display of the medicaldevice, days during which treatment was applied and days during whichtreatment was not applied. Indicating compliance with a treatmentregimen by displaying a calendar that indicates the days during whichtreatment was applied and the days during which treatment was notapplied. Receiving payment for a number of treatments. Receiving paymentfor a number of treatments includes receiving payment at the medicaldevice for a number of treatments, the payment being entered with acode, a credit card, or a SIM card.

In another general aspect, a computer-implemented method includes:receiving user input that a treatment should be initiated using atreatment module of a medical device; in response to receiving the userinput, controlling the treatment module to apply a treatment; recordingon one or more data storage devices information indicating occurrencesof treatment using the treatment module; and indicating, on a display ofthe medical device, days during which treatment was applied and daysduring which treatment was not applied.

Implementations of any of the aspects may include one or more of thefollowing features. For example, indicating days during which treatmentwas applied and days during which treatment was not applied includesindicating the days during which treatment was applied and the daysduring which treatment was not applied on a calendar. Indicating thedays during which treatment was applied and the days during whichtreatment was not applied on a calendar includes marking days of thecalendar during which treatment was applied with a check mark anddisplaying days of the calendar during which one or more treatments werenot applied as unchecked. Storing information about a treatment regimenfor use of the medical device, and indicating compliance with thetreatment regimen on the calendar. Indicating the days during whichtreatment was applied and the days during which treatment was notapplied occurs in response to the medical device being powered on.Determining the geographic location of the medical device, anddisallowing commencement of treatment using the treatment module if thedetermined geographic location is outside an authorized geographiclocation. Determining user identity, and disallowing commencement oftreatment using the treatment module if the determined user identitydoes not match an authorized identity. Controlling the treatment moduleto apply a treatment includes controlling the treatment module toproduce a pulsed ultrasound signal having a frequency in the range of 1MHz to 2 MHz, consisting of pulses generated at a rate in the range of100 Hz to 10 KHz with each pulse having a duration in the range of 10microseconds to 2,000 microseconds. The pulsed ultrasound signal has apower intensity of 100 milliwatts per square centimeter or less.

According to another general aspect, a computer-readable storage mediumstoring instructions that, when executed by one or more processingdevices, cause the one or more processing devices to perform theoperations of the computer-implemented methods.

According to another general aspect, a medical device includes: at leastone treatment module configured to apply a treatment to a patient, thetreatment module including at least one ultrasound transducer and atleast one driver circuit coupled to the ultrasound transducer; aninterface configured to operatively connect to a removable storagedevice storing authorization data that identifies a level of treatmentauthorization; and at least one processing device. The at least oneprocessing device is configured to perform the following in response toreceiving user input indicating a treatment should be initiated:determine whether the removable storage device is valid for use with themedical device; if the removable storage device is determined to bevalid, access the authorization data; determine whether the treatment isauthorized based on the accessed authorization data; if the treatment isdetermined to be authorized, control the treatment module to apply thetreatment by producing ultrasound with therapeutic properties; and ifthe treatment is determined to not be authorized, control the treatmentmodule such that the treatment is not applied.

The details of one or more implementations are set forth in theaccompanying drawings and the description below. Other features andadvantages will become apparent from the description, the drawings, andthe claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of a medical device.

FIG. 2 is a block diagram of the medical device.

FIG. 3 is a diagram of the medical device configured to displayinformation.

FIG. 4 is a chart illustrating examples of information that may bedisplayed.

FIG. 5 is a flow diagram illustrating a process for displayinginformation.

FIGS. 6A to 6C are diagrams illustrating user interfaces for the medicaldevice.

FIG. 7 is a diagram illustrating a medium for authorizing treatmentusing the medical device.

FIG. 8 is a diagram of a system for authorizing medical treatments.

FIGS. 9A and 9B are flow diagrams of a process for authorizing medicaltreatments.

FIG. 10 is a diagram of a process for storing patient information.

FIG. 11 is a diagram of the medical device.

FIG. 12 is a diagram of a main operating unit of the medical device.

FIG. 13 shows authorized geographic areas.

FIG. 14 is a block diagram of geo-locking components of the medicaldevice.

FIG. 15 is a block diagram of device authorization components of themedical device.

FIG. 16 is a flowchart depicted use of the medical device.

DETAILED DESCRIPTION

In some implementations, a medical device can control its operation toapply treatments that have been purchased and to not apply treatmentsthat have not been purchased. For instance, the medical device can beauthorized to provide a particular number of treatments purchased for apatient. When the purchased treatments are exhausted, the medical devicecan be authorized to perform additional treatments based on additionalpayment. For example, a user can purchase a card or other removablemedium that authorizes a number of additional, prepaid treatments withthe medical device. The medical device can access authorization datastored on the removable medium, determine that treatment is authorized,and perform the appropriate treatment.

In addition, or as an alternative, to the above-mentioned features, themedical device can also store information and provide information to apatient. For example, the medical device may provide instructions forusing the medical device or information about a particular healthcondition. The medical device can select the information to providebased a particular health condition of the patient or other informationabout the patient.

In addition, or as an alternative, to the above-mentioned features, themedical device can record compliance information that indicatesoccurrences of treatments using the medical device. Days and/or timesthat a patient has performed treatments using the medical device can berecorded. The compliance information can also indicate the degree towhich a patient has complied with a particular treatment regimen.

In addition, or as an alternative, to the above-mentioned features, themedical device can display information to a patient that indicates therecorded compliance information. The medical device can display acalendar indicating days on which treatment was performed and days onwhich treatment was not performed. The calendar can also indicatewhether or not the treatments that were performed occurred according tothe scheduled treatments indicated by a particular treatment regimen forthe patient.

In addition, or as an alternative, to the above-mentioned features, themedical device can limit restrict unauthorized use based on an identityof a user or the geographical location of the medical device. Themedical device can determine the geographic location of the medicaldevice and not allow treatment to commence if the determined geographiclocation is outside an authorized geographic region. The medical devicecan also determine the identify of a user and not allow treatment if thedetermined identity is not any authorized identity.

Some implementations of the medical device may provide the followingadvantages. For example, rather than incur a large initial expense bypurchasing a medical device with unlimited treatments, in someinstances, a patient or third-party payer may pay for only thetreatments that are prescribed to the patient. By purchasing treatmentsas needed, patients and third-party payers may also spread expenses overtime. Also, when treatments can be authorized after an initial set oftreatments is exhausted, the additional use of the medical device can beeasily added. Additional treatments can generally be authorized withoutservice, repair, or reconditioning of the medical device. In someinstances, the patient may enter payment directly at the medical deviceand receive treatment with minimal delay after payment is complete. Inaddition, by providing only treatments that have been purchased,excessive treatment and misuse of the medical device can be deterred.

Some implementations of the medical device may provide the followingadditional advantages. Information can be displayed to the patientduring treatment, including, for example, information about a healthcondition of the patient, instructions for using the medical device, andinformation about the patient's compliance with a treatment regimen.Messages may, for example, encourage, motivate, inform, entertain, andinstruct the patient.

Some implementations of the medical device may provide the followingadditional advantages. Information indicating a patient's usage of amedical device over time and compliance with a treatment regimen can bedisplayed. The patient's compliance with a treatment regimen can beeasily discernable from a calendar display indicating days on whichtreatment occurred.

Some implementations of the medical device can limit use by unauthorizedusers. Some implementations of the medical device can also limit useoutside an authorized geographical area.

Referring to FIG. 1, a patient is shown using a medical device 10 thatincludes a treatment module for applying a treatment to the patient. Inthe example illustrated, the medical device 10 is a portable ultrasonictreatment device. The treatment module may include, for example, one ormore ultrasound transducers 16 and at least one driver circuit coupledto the ultrasound transducers 16.

The medical device 10 can include a control unit 12 that controls theoperation of the transducers 16. The control unit 12 can include thetransducer driver circuit. The medical device 10 can also include cables18 that can carry power, data, and control signals between the controlunit 12 and the transducers 16.

The medical device 10 can include a placement module 14 that couples thetransducers at a location of the patient's body where treatment isneeded, for example, over a fractured bone or next to damaged connectivetissue. The placement module 14 can include a band, sleeve, applicator,or other connector to fasten the one or more transducers to a treatmentsite. An ultrasound conducting gel 20 can be applied to the skin of thepatient to enable the ultrasound to propagate effectively to thepatient's tissue.

The medical device 10 can use low intensity, high-frequency acousticenergy (ultrasound) to treat injuries, defects, or pathologies. Forinstance, the ultrasonic treatment device can be designed to treatinjuries, defects, or pathologies of bones or connective tissue, and, insome instances, can increase cellular level activity that leads tohealing of ischaemic or grafted tissue. The medical device 10 may beused as an adjunct to surgical repair, in order to speed healing, or insome cases can be used alone to heal tissue injuries without surgery(e.g., for degenerative diseases such as osteoarthritis, tendonosis, andtendonitis). The medical device 10 can be suitable for use in treatmentof bone fractures and/or connective tissues associated with joints, suchas those in the hand, foot, wrist, ankle, knee, elbow, hip, shoulder,back, and neck.

For example, following surgery, the medical device 10 can be appliednon-invasively to the outside of the body (e.g., coupled to the skinwith coupling media, such as a gel) in the region of the repairedtissue. The medical device 10 can be operated to transmit ultrasound(for example, in the form of pulses) into the tissue in need oftreatment, or at the interface with the uninjured tissues. Exposure tothe ultrasound can stimulate a faster, better quality repair of thetissue. At a bone interface, the ultrasound can also stimulate bonerepair and bone ingrowth into repair or graft tissue. This can give riseto a faster, stronger repair and improved integration of the interfacebetween, for example, tendon, ligament, and bone. The ultrasonictreatment device may also be used to non-invasively treat pathologies ofconnective tissues, such as osteoarthritis, ligament and tendonconditions, without the need for a surgical procedure.

Referring to FIG. 2, the control unit 12 of the medical device 10 caninclude a processing device 50 that executes instructions stored on astorage device 52. The processing device 50 can include one or moreprocessing devices. The storage device 52 can include one or morestorage devices, one or more of which may be removable. The control unit12 can also include a driver circuit 54, a user interface module 60, apayment module 62, a communication module 64, and a power supply 68.

By executing the instructions, the processing device 50 can, forexample, determine whether a treatment is authorized. If treatment isauthorized, the processing device 50 can control the treatment module(for example, driver circuit 54 and transducers 16) to apply thetreatment. Applying the treatment can include controlling the drivercircuit 54 to produce ultrasound with therapeutic properties.Controlling the driver circuit 54 to produce ultrasound can includeactivating the driver circuit 54, for example, supplying power to thedriver circuit 54, sending control signals to the driver circuit 54, orcausing the driver circuit 54 to produce a particular output. If thetreatment is not authorized, the processing device 50 can control thetreatment module such that the treatment is not applied. For example,the processing device 50 can control the driver circuit 54 such thatultrasound with therapeutic properties is not produced. Controlling thedriver circuit to not apply treatment can include not activating thedriver circuit 54, deactivating the driver circuit 54, setting theoutput of the driver circuit 54 (for example, setting the amplitude tozero), and/or otherwise limiting or preventing treatment. The processingdevice 50 can also be configured to control other components describedbelow, for example through instructions stored on the storage device 52.

The processing device 50 can determine whether a treatment is authorizedby, for example, accessing authorization data. If, for example, accessedauthorization data is invalid, is for a different medical device 10, hasexpired or all treatments associated with the code have been expended,or if no authorization data can be accessed, the processing device 50can determine that treatment is not authorized. On the other hand, ifvalid authorization data can be accessed, the processing device 50determines whether at least one treatment using the medical device 10 isauthorized. The authorization data may or may not include anauthorization code that indicates that payment for treatments hasoccurred. The authorization data can be stored in the storage device 52,for example, or, as described further below, in a removable medium.

The storage device 52 can store a device identifier, such as a serialnumber, that identifies the particular medical device 10. The deviceidentifier can uniquely identify the medical device 10 and distinguishit from all other ultrasonic treatment devices, even those of the sametype or model. The storage device 52 can also store information aboutthe treatments that are authorized for the medical device 10, forexample, a number of treatments that are authorized or an authorizationcode that authorizes treatments.

The driver circuit 54 can be configured to send drive signals that causethe transducers 16 to generate ultrasound with therapeutic properties.The driver circuit 54 can include a signal generator 56 that generates asignal and a transducer driver 58 that drives the transducers 16according to the generated signal. In an implementation, the ultrasoundgenerated by the transducers 16 can include low intensity ultrasound(for example, 100 mW/cm² or less) having a frequency ranging betweenabout 1 and 2 MHz, more particularly about 1.5 MHz. The ultrasound canbe pulsed, with a pulse width ranging from about 10 to 2,000microseconds, more particularly about 200 microseconds, with arepetition frequency ranging from about 100 Hz to about 10 KHz, moreparticularly about 1 KHz.

The user interface module 60 can provide information to the patient andenable treatment to be initiated. The user interface module 60 mayinclude one or more input devices or controls, for example, buttons, akeypad, or a touch-sensitive screen. The user interface module 60 may beused by a patient or other person, for example, to enter user input thatindicates that a treatment should be administered by the medical device.When the processing device 50 determines that treatment is notauthorized, the processing device 50 can provide an indication to thepatient on the user interface module 60 that more treatments need to bepurchased.

The user interface module 60 may also include one or more outputdevices, for example a screen, a liquid crystal display, or lights. Forexample, the interface module 60 can include a screen 72, for example, aliquid crystal display (LCD), a thin-film transistor (TFT) display, afield sequential display, or an organic light-emitting diode (OLED)display. The interface module 60 can also include light-emitting diodes(LEDs) and other indicators. The interface module 60 may include aspeaker or other device that can produce sound (not shown), or otheroutput devices. The user interface module 60 may also include inputcapabilities or input devices (not shown), for example, buttons, one ormore keypads, and other controls. The screen 72 may be touch-sensitiveto receive input from a user. The user interface module 60 can alsoinclude an interface to access a removable storage medium, such as asubscriber identity module (SIM) card, a Secure Digital (SD) card, orother types of removable storage media.

The payment module 62 can enable a patient to enter payment at thecontrol unit 12, or to receive information indicating prior payment.Payment can be enabled through one or more methods. The payment module62 can include a credit card reader that reads a card and chargestreatment to a credit card, debit card, or similar card that is swipedat the control unit 12. The payment module can include a SIM cardreader, and a patient may purchase a SIM card that includes informationthat represents one or more payments made for treatment with theultrasonic treatment device. The payment module can include a reader forreading other types of removable media, for example, a SD card or otherflash memory device. The control unit 12 can be configured to receivepayment in the form of a code or other user input that may be entered onthe interface module 60. Some implementations may exclude the paymentmodule 62. For instance, in some implementations, provisions may be madeto allow payment remotely from the device 10, for example, at a computerconnected to a network.

The communication module 64 can be configured to send paymentinformation to a remote system and/or receive authorization informationthat authorizes additional treatments using the medical device 10.

In some implementations, the processing device 50 is configured toreceive an authorization code or other authorization data through thecommunication module 64 and to store the received authorization code inthe storage device 52. The communication module 64 can enablecommunication with a server system, client system, or other computersystem over a wired or wireless connection. The communication module 64may enable a communication link that is wired or wireless. Thecommunication module may enable communication over, for example,Ethernet, Universal Serial Bus, 502.11, Bluetooth, Zigbee, cellularnetworks, and other communication links. In one implementation, thecommunication module 64 can include a cellular transceiver 66 to receiveand/or transmit information over a cellular network. The communicationmodule 64 may also enable communication through multiple communicationlinks.

The communication module 64 can be configured to send paymentinformation to a remote system and/or receive authorization informationthat authorizes additional treatments using the medical device 10. Theprocessing device 50 can be configured to receive an authorization codethrough the communication module 64 and to store the receivedauthorization code in the storage device 52.

A power supply 68 can provide power to the components of the medicaldevice 10, including the driver circuit 54, the processing device 50,the storage device 52, the payment module 62, the communication module64, and the user interface module 60. The power supply 68 can include abattery that is integrated into the control unit 12 or is removable. Thebattery can be primary battery or a rechargeable battery, and the powersupply 68 can include a detachable power adapter that can charge arechargeable battery.

When a user performs treatment using the medical device 10, the medicaldevice 10 can collect and store compliance information. Collectingcompliance information can include recording information about use ofthe medical device 10, for example recording the number of treatmentsthat are performed. Compliance information can include a number oftreatments provided by the medical device 10, a date and time that atreatment was provided by the medical device 10, and/or a duration thata treatment was provided by the medical device 10. Information aboutmultiple uses or treatments with the medical device 10 can be collected.

A treatment regimen that identifies a prescribed use of the medicaldevice 10 can be identified. For example, the treatment regimen may beentered on the device after the health condition has been diagnosed orafter the medical device 10 has been prescribed to the patient.Information about a treatment regimen may be entered on the medicaldevice 10 or received from a network, which may include a cellularnetwork. The information about the recorded use of the medical device 10can be compared to the information about the prescribed use of themedical. Information indicating the degree that the recorded use matchesthe prescribed use can be generated.

Compliance information can be stored on the storage device 52, on aremovable medium, or both the storage device 52 and a separate removablemedium. The compliance information may, but is not required to, includeone or more results of a comparison between the recorded use of themedical device 10 and the treatment regimen of the patient.

Referring to FIG. 3, the medical device 10 can display information tothe patient. For example, the medical device 10 can display informationthat relates to the particular patient using the medical device 10, forexample, information about a health condition of the patient, atreatment regimen of the patient, or a physician of the patient. Theinformation displayed on the medical device 10 can thus be personalizedto the particular patient that receives the medical device 10 and aparticular health condition of the patient. In some instances, theinformation displayed may be selected to instruct, encourage, orentertain the patient. In addition, the information can provideadvertisements and personalize treatment using the name or brand of, forexample a particular physician, hospital, or insurance company.

The information displayed on the medical device 10 may be organized intoa plurality of messages 304. Messages 304 can include a variety ofmedia, including text, images, video, and sound. Messages 304 can bestored on the storage device 52 of the control unit 12. Some messages304 may be entered onto medical device 10 during manufacturing. Forexample, an initial set of predetermined messages 304 may be loaded ontoa storage device 52 before it is shipped. Messages 304 may also beentered at other times to supplement the initially loaded messages 304,including before a medical device 10 is dispensed to a patient and aftera patient begins use of the medical device 10. Messages 304 may bereceived with, for example, the communication module 64 and may bestored on the storage device 52.

Messages 304 can include information related to specific healthconditions. For example, some messages 304 may relate to treatment ofbroken bones of the foot, and others may relate to treatment of brokenbones of the arm. The medical device 10 can store messages 304 thatrelate to a wide variety of health conditions. To ensure that themessages 304 displayed to the patient are useful, the processing device50 can access information that identifies a health condition of thepatient, which can be stored on the storage device 52. Based on theidentified health condition, the processing device 50 can select one ormore messages out of the set of messages 304 that are stored on thestorage device 52. For example, if the processing device 50 determinesthat the patient has a broken foot, the processing device 50 can selectone or more messages 304 related to broken bones of the foot andtreatment of a broken foot. The selected messages 304 can be displayedto the patient on the screen 72. In some implementations, the screen 72may be part of the interface module 60, while in others the 72 screenmay be integrated into the control unit 12.

Selected messages 304 can be displayed to the patient during treatment.For example, while a treatment is applied, the medical device 304 candisplay information to instruct the patient about proper use of themedical device 10. In many instances, a patient receives only minimalinstruction about the proper use of the medical device 10 when themedical device 10 is dispensed to the patient. A patient may forget theproper use of medical device and the details of a treatment regimen,especially when the medical device 10 is new. By providing messages 304that instruct the patient how to use the medical device 10, the patientmay be more likely to perform treatment correctly. The instructivemessages 304 can be selected based on the health condition of thepatient and the associated treatment regimen for the health condition.

The medical device 10 can select and display a variety of other messages304 during treatment. For example, messages 304 can also provide generalhealth information, such as, “smoking inhibits bone healing” or “tellyour doctor if you use blood thinners.”

Messages 304 can also be selected based on a patient's compliance to atreatment regimen. The medical device 10 can store information thatindicates when the patient should receive treatment. The medical device10 can also record information indicating when treatment is actuallyperformed. The medical device 10 can compare the planned or prescribeduse of the medical device with the actual use of the device anddetermine how well the patient has complied with the prescribedtreatment regimen. The medical device 10 can display messages 304 to thepatient that directly or indirectly provide compliance information. Forexample, messages can provide direct feedback about a patient'scompliance. Messages 304 can also be displayed that motivate, encourage,and remind the patient to follow a consistent treatment schedule.Messages 304 can also describe the benefits of continuing treatment orprovide information about how the medical device 10 operates.

Messages 304 can also provide physicians and others an opportunity toprovide a personalized message. For example, one or more messages 304may include the name of a patient's physician, the name of the patient'sinsurance company, or the logo for a hospital. Customized messages 304can enable physicians and organizations to reinforce their brands andenhance the patient's experience during treatment. Messages 304 can alsoinclude contact information, for example, the phone number for thepatient's primary physician. Messages 304 can include advertisements andpaid content.

Messages 304 can also be provided to entertain a patient duringtreatment and thus encourage the patient to complete the treatment. Insome implementations, the medical device may enable the patient toacquire or input additional content to display on the medical device.

Referring to FIG. 4, a diagram illustrates the selection and display ofmessages 304 on a screen 72 of the medical device 10.

The processing device 50 of the medical device 10 can access informationidentifying a health condition of a patient. As illustrated, a healthcondition record 401 indicates that the health condition of the patientis a broken clavicle. Based on the identified health condition, theprocessing device 50 can select one or more messages from a plurality ofmessages 304. The plurality of messages 304 may include a set 402 ofpredetermined messages 304. Each message 304 in the set 402 may beassociated with an identifier, as represented by the numbers from one toten. From the set 402, a subset 403 of messages 304 may be selected. Theselected messages 304 can include messages 304 that relate to theparticular health condition of the patient. The selected messages 304can be ordered into a sequence 404 for display on the medical device 10.

The sequence 404 of messages 304 may be displayed on the screen 72 ofthe medical device 10. In one implementation, the sequence 404 ofmessages 304 may begin to be displayed when treatment begins, and thesequence 404 may end roughly when treatment ends. In addition to themessages 304, other information can be included, for example,information that describes the treatment being performed. For example,notifications 406 that indicate the time remaining until treatment iscompleted may be interspersed between other messages 304.

The messages 304 selected and the sequence 404 of the selected messages304 can vary according to the needs of the patient and to limitunnecessary repetition. For example, instructions about how to use themedical device 10 may be selected and displayed for an initial set oftreatments using the medical device 10, but instructions may be omittedafter many treatments have successfully been performed.

Referring to FIG. 5, an example of a process 500 for providinginformation is illustrated. The processing device 50 of the medicaldevice 10 can be configured to perform the process 500, for example, byexecuting instructions stored on the storage device 52.

A plurality of messages is stored on the medical device (502). Forexample, the storage device may store the plurality of messages.Messages may be entered on the storage device by a manufacturer of themedical device before the medical device is sold. Messages can also beentered on the storage device by sales representatives, physicians, andothers at other times.

The medical device receives information about a health condition of apatient (504). For example, after a patient is diagnosed with aparticular health condition, the health condition can be entered on themedical device. A physician, assistant, sales representative, or otherperson may enter information that indicates the health condition of thepatient on the medical device. In addition, or alternately, the medicaldevice may receive information about a health condition of the patientthrough the communication module. For example, the medical device mayreceive information about a prescription or diagnosis automatically overa network, without requiring any manual input. The medical device canstore the information about the patient's health condition for lateraccess. The health condition can be, for example, a health conditionthat is treatable by the medical device.

The medical device selects messages for the patient (506). For example,the messages can be selected from the stored messages stored on thestorage device. One or more messages can be selected based on theidentified health condition of the patient. For example, if the patienthas a broken ankle, messages can be selected that describe treatment ofa broken ankle. The selected messages can include messages related tomultiple health conditions. The selected messages can includeinstructions for using the medical device. The selected messages caninclude one or more messages that include information about a doctorthat treated the patient or a medical office where the patient wastreated. The selected messages can include one or more messages aboutthe medical device or information about the provider of the medicaldevice. The selected messages can include advertisements. The selectedmessages can include image data or video data.

In some implementations, the medical device can store records indicatinguse of the medical device. For example, the medical device can recordthe number of treatments that have been performed using the medicaldevice, the date and time that each treatment is performed, and/or theduration of each treatment. The information in these records, referredto generally as compliance information, indicates the manner in whichtreatments were performed using the device, from which a patient'scompliance with a particular treatment regimen can be determined.

Compliance information can be stored on the one or more storage devices52. For example, the compliance information can be stored on internalmemory of the medical device 10 and can also be stored on a removablemedium, such as an SD memory card. Recording the compliance informationon internal memory and the removable medium provides a backup in caseone of the storage devices should fail. Additionally, the removablemedium may be removed and used to transfer compliance information toother systems.

The medical device can also identify a treatment regimen thatcorresponds to the health condition. For example, the medical device mayreceive the information from a prescription, a treatment regimen that isentered directly on the medical device, or the medical device may storea number of treatment regimens on the storage device. The medical devicecan access the records indicating use of the device. The medical devicecan compare the records indicating use of the medical device to thetreatment regimen identified for the health condition of the patient.

The medical device can provide an indication of compliance with thetreatment regimen. For example, the medical device may provide anindication of compliance in one or more messages that are selected to belater displayed to the patient. The selected messages can also encouragecompliance to a treatment regimen, for example, by praising the patientfor past compliance or assuring the patient that continued treatmentwill bring good results. The selection of messages, including theselection of messages about compliance to the treatment regimen, can bebased on the number of uses of the medical device indicated in therecords that indicate use of the medical device.

The medical device can also identify the language of the patient andselect one or more messages in the language of the patient. Theplurality of messages stored on the medical device can include messagesin at least two languages. For example, some or all of the storedmessages can be included in multiple languages. The medical device canidentify the language of the user, for example, based on user input,messages input on the medical device, information received by thecommunication module, or other information.

The medical device can begin treatment (508). For example, a patient mayenter input indicating that treatment should begin, and the medicaldevice may control a driver circuit to drive an ultrasound transducer sothat the ultrasound transducer produces ultrasound with therapeuticproperties. The medical device can store and update records indicatinguse of the medical device.

The medical device can display the selected messages (510). The selectedmessages can be displayed during treatment, for example, while theultrasound with therapeutic properties is applied to the patient. Themessages can be displayed on a liquid crystal display or other screen.

Referring to FIG. 6A, the medical device 10 can display informationabout a patient's compliance with a treatment regimen on a userinterface 600 a. The user interface 600 a can be displayed on the screen72 of the user interface module 60. The user interface 600 a includes acalendar view 602 that indicates whether treatment was performed eachday of, for example, the current month, or the current month andprevious months. In the calendar space corresponding to each day thattreatment was performed, a compliance indicator 604 can be displayed,for example, a colored square, a check mark, or other image or icon. Inthe space corresponding to each day in which treatment was notperformed, a noncompliance indicator 606 can be displayed, for example,a different image or icon, such as a blank square or a red “X.” Thus theuser interface 600 a can visually distinguish the days during whichtreatment was performed from days during which treatment was notperformed, providing an easily-understandable indication of recentcompliance with the treatment regimen.

In some implementations, information about the particular treatmentregimen prescribed for the user of the medical device 10 is stored onthe medical device 10, and the compliance indicator 604 is displayed toindicate that a treatment performed on a particular day complies withthe particular treatment regimen prescribed. In other words, rather thanassuming that the treatment regimen requires one treatment each day, themedical device 10 compares times that treatments were performed to timesthat treatments were scheduled to be performed, as dictated by atreatment regimen. If a treatment regimen involves treatment every otherday, for example, a neutral indicator can be displayed to represent daysin which treatment was not scheduled and was not performed. The neutralindicator may be, for example, the day of the month that the day occurs.The noncompliance indicator 606 may be displayed, for example, only whentreatment was scheduled to be performed on a day and treatment did notoccur on that day. If treatment was performed on a day that treatmentwas not scheduled, an improper treatment indicator different from thenoncompliance indicator 606 may be displayed for that day,distinguishing noncompliance by omitted treatment from noncompliance byperformance of an unscheduled treatment. As a result, compliancerelative to a treatment regimen can be accurately indicated whenscheduled treatments are not scheduled every day.

Similarly, compliance can be indicated for treatment regimens thatdictate treatment multiple times in a day. For example, multiplecompliance indicators 604 or multiple noncompliance indicators 606 canbe displayed to indicate each treatment that was completed or missedthat day.

In other implementations, the medical device 10 displays the complianceindicator 604 for days that treatment was performed and displays thenoncompliance indicator 606 for days that treatments were not performed,without regard to times that treatments were dictated by a prescribedtreatment regimen. Thus even when the medical device 10 does not haveaccess to information indicating a treatment regimen, the calendar view602 indicates when treatments were performed, permitting the user orothers to determine compliance with an appropriate treatment regimen.

The user interface 600 a may display patient compliance for time periodlonger or shorter than a month, and for previous periods of time ratherthan, for example, the most recent weeks or months.

The medical device 10 can automatically display the calendar view 602 asthe medical device 10 is powered on or at other times. For example, eachtime the medical device 10 is powered on, while the medical device 10 isinitializing and for a period of time afterward, the calendar view 602showing compliance can be displayed. The calendar view 602 can also bedisplayed to physicians, caretakers, and others. The calendar view 602can be displayed automatically after particular functions of the medicaldevice 10 are accessed, or in response to a request that the calendarview 602 be displayed.

The medical device 10 can automatically display a total complianceto-date indication. For example, if ten days have elapsed since thestart of a daily treatment regimen and the patient only used the devicefor eight out of the ten days, then the total compliance indicator candisplay 8/10 or 80% to indicate the overall level of compliance.

The user interface 600 a can also display notification icons 610. Thenotification icons 610 can vary in appearance according to the currentstatus of the medical device 10. The notification icons 610 canindicate, for example, the status and availability of communicationlinks such as wireless connections, whether service is needed, thaterror or notification messages are available, the types or quality ofconnections with various modules, the remaining battery charge of themedical device, and other notifications.

Referring to FIG. 6B, after the calendar view 602 is displayed, or afterreceiving user input, the medical device 10 can display a treatmenttimer 612 on a user interface 600 b. The treatment timer 612 canindicate the time remaining before a treatment is completed. Forexample, for a twenty-minute treatment, the treatment timer 612 caninitially indicate the duration of treatment, twenty minutes. While atreatment is in progress, the treatment timer 612 can count down towardzero, reaching zero when the treatment ends. The notification icons 610can also be displayed.

Referring to FIG. 6C, an alternative user interface 620 includes acalendar view 622 indicating daily compliance with the treatment regimenand a treatment timer 624. Days for which treatment was performed asindicated in the treatment regimen are indicated with a first marking626, while days for which planned treatment failed to be performed areindicated with a different marking 628. Days in the future can be markedwith their corresponding calendar numbers.

Referring to FIG. 7, a removable medium 710, for example, an SD card,USB device, or other removable memory device, can be used to authorizeuse of the medical device 10. The removable medium 710 can storeauthorization data 720 that indicates a level of treatmentauthorization, for example, a number of treatments authorized or anamount of treatment time authorized using the medical device 10.

The medical device 10 can include an interface 712 that operativelyconnects to the removable medium 710, permitting the processing device50 to access the authorization data 720. The interface 712 can include aslot that receives the removable medium 710 within the medical device10. The slot can be accessible to a user, permitting the user to replacethe removable medium 710 with a different removable medium. The controlunit 12 of the medical device 10 can define the slot and can include acover that covers the slot.

To obtain treatment authorization, the patient can obtain the removablemedium 710, which can be a prepaid medium that represents that paymenthas been made by or for the user. Removable media can store differinglevels of treatment authorization. Different removable media may be soldwith authorization data 720 that permits, for example, 50, 25, or 10treatments. Treatment authorization may additionally or alternatively beindicated as an amount of time, for example, 1000, 500, or 100 minutesof treatment. In some implementations, the removable medium 710 can bepurchased from a retail store or a physician's office. The fact that thepatient obtained the removable medium 710 indicates that payment wasmade, and no additional verification of payment may be necessary to usethe medical device 10.

The removable medium 710 may be a secure mode of communicating that aparticular number of treatments are authorized. The removable medium caninclude a copy-protection or anti-counterfeiting feature that can beused to determine whether the removable medium is genuine. For example,the removable medium can store an encoded value in a manner that thevalue is not easily duplicated or copied from one removable medium toanother. The encoded value can be hardware-encoded or factory-set with aphysical setting such that similar removable media cannot be altered tomimic the encoded value. In some implementations, the encoded value is aserial number that is embedded in non-writable storage of the removablemedium. Each valid removable medium can have a unique serial number.Only removable media that have a serial number within a predeterminedrange of values can be considered genuine.

In use, a user interacts with the medical device 10 to indicate thattreatment should be initiated, for example, by pressing a button orentering other input. In response, the processing device 50 determineswhether a removable medium is present. If no removable medium ispresent, the processing device 50 disallows treatment.

If a removable medium such as the removable medium 710 is present, theprocessing device 50 determines whether the removable medium 710 isvalid for use with the medical device 10. For example, the processingdevice 50 determines whether a serial number or other value encoded inthe removable medium meets predetermined criteria. In someimplementations, the processing device 50 determines whether the valueis within a predetermined set or range of values. The serial number canbe a value that is not modifiable by a user, for example, a value thatis fixed in the hardware configuration of the removable medium andcannot be copied onto a similar removable medium. Thus the processingdevice 50 can verify that the physical medium is valid. If a removablemedium is not genuine, or is not compatible with or intended for themedical device 10, the processing device 50 disallows treatment.

If the removable medium 710 is genuine, the processing device 50accesses authentication data 720 stored on the removable medium 710. Theauthentication data 720 can indicate a number of treatments authorizedor a number of treatment minutes that treatment is authorized. Forexample, when each treatment has a duration of twenty minutes, theauthorization data 720 may indicate that ten treatments are authorized,or may indicate that two hundred minutes of treatments are authorized.If the authorization data 720 indicates that at least one treatment isauthorized, or that one or more treatment minutes are authorized, theprocessing device 50 controls the treatment module to provide ultrasoundwith therapeutic properties. If the authorization data 720 indicatesthat no treatments are authorized, the processing device 50 disallowstreatment.

After the medical device 10 applies a treatment, the processing device50 alters the authorization data 720 to indicate an updated level ofauthorization. For example, the medical device 10 can decrease thenumber of authorized treatments or decrease the number of authorizedtreatment minutes remaining Modified authorization data that indicatesan updated level of authorization can be stored on the removable medium710, for example, by overwriting the authorization data 720 that wasstored before treatment began.

The medical device 10 can also store compliance data 730 on theremovable medium 710. When the medical device 10 applies a treatment,the processing device 50 can store information about the treatmentperformed. For example, the compliance data 730 can indicate the time,date, and duration of the treatment applied, along with other treatmentinformation. The removable medium 710 can thus include a compliance logthat indicates use of the medical device 10 over time. The compliancedata 730 can also indicate, for example, the degree that the use of themedical device 10 corresponds to planned or prescribed use of themedical device 10. For example, the compliance data 730 can indicatedays or times at which treatment was scheduled and whether treatmentoccurred at those days or times. Compliance data 730 can additionally oralternatively be stored on an internal storage device of the medicaldevice, such as the storage device 52.

In some implementations, the authentication data 720 is encrypted, whichcan discourage tampering. In such implementations, the processing device50 decrypts the authentication data 720 before determining whethertreatment is authorized. Also, after modifying the authentication datato indicate a decreased level of authorization, the processing device 50encrypts the modified data and stores the encrypted data on theremovable medium 710.

When additional treatments are desired, for example, after the treatmentauthorization of the authorization data 720 is depleted, a user canobtain a different removable medium that includes authorization data foradditional treatments.

In some implementations, the authorization data 720 directly authorizesthe treatments, without the medical device 10 needing additionalinformation or confirmation from another system. In someimplementations, as described below, the medical device 10 verifies theauthenticity of authorization data 720 by communicating with a serversystem or other device.

Referring to FIG. 8, a system 800 for authorizing medical treatmentsincludes the medical device 10 connected to a server system 802 via anetwork 806. The system 800 can also include a third-party server system804 and a cellular network 808. After payment is made by or for apatient, authorization data can be entered at or received by the medicaldevice 10. The authorization data indicates a level of treatmentauthorization, and can include an authorization code.

A patient may desire to authorize medical treatments using theultrasonic treatment device 10. For example, the patient may receive theultrasonic treatment device 10 in a condition in which treatments havenot yet been authorized. As another example, the patient may have usedtreatments authorized for the ultrasonic treatment device 10 so that aninsufficient number of treatments are currently authorized to completetreatment.

To purchase additional treatments of the medical device 10, the patientmay provide payment information 810 at the medical device 10. Paymentinformation 810 includes payment entered or authorized at the medicaldevice 10 and also information that indicates that payment has been madein another manner. For example, the patient may enter a credit card, adebit card, or another payment device into an appropriate reader of themedical device 10 and authorize a charge to an account owned by thepatient. The patient may also enter an account number on the userinterface module 60 of the medical device 10 to authorize payment. Thepatient may also purchase a prepaid medium, for example, a SIM card, aSecure Digital (SD) card, or a prepaid card with a magnetic strip, anoptical code, or a printed code, from a store or physician's office. Inone implementation, the prepaid medium may be a secure mode ofcommunicating an amount of payment that has been paid. The patient mayenter the prepaid medium at the ultrasonic treatment device 10 toindicate that payment has been made. The patient may also purchasetreatments in a store or through a web site, may receive a confirmationcode for the transaction, and may enter the confirmation code at theultrasonic treatment device 10. The system 800 can also be used toverify the validity of an authorization code received from a prepaidmedium.

The medical device 10 can send the payment information 810 to a serversystem 802. The payment information 810 can be associated with a deviceidentifier 812 that identifies the medical device 10, which can also besent to the server system 802. In addition to, or instead of, sending adevice identifier 812, the medical device 10 may send a patientidentifier that identifies the patient, together with the paymentinformation. As will be described in greater detail below, the serversystem 802 can send an authorization code to the medical device 10 afterreceiving the payment information 810 and the device identifier 812.

The medical device 10 may send the payment information 810 and thedevice identifier 812 to the server system 802 through the network 806.Alternatively, or additionally, the medical device 10 may initiate acommunication using the cellular network 808 to send the paymentinformation 810 and the device identifier 812 to the server system 802.Payment information 810 can also be received through a removable medium,token, code or other indication that treatment is authorized.

In one implementation, a prepaid medium can store an authorization codethat can directly authorize treatments, so that the ultrasonic treatmentdevice 10 is not required to transmit any information to the serversystem 802. A prepaid medium can include an authorization code that canenable treatments of the ultrasonic treatment device 10, independent ofa server system 802. For example, a patient may purchase a SIM card orother device that stores an authorization code compatible with theultrasonic treatment device 10. The SIM card containing theauthorization code can be entered at the ultrasonic treatment device 10and the treatments authorized by the authorization code can be enabledon the ultrasonic treatment device 10. Payment is received by the retailstore or physician's office where the prepaid medium was obtained. Thefact that the patient obtained the prepaid medium proves that paymentwas made, and no additional verification may be necessary. In someimplementations, the ultrasonic treatment device 10 may verify that theauthentication code included with the prepaid medium is authentic, andmay ensure that the authentication code of the prepaid medium is notused multiple times (for example, by altering the data on the prepaidmedium). In another implementation, a mechanical device or key may alsobe used to indicate authorization of additional treatments of theultrasonic treatment device 10.

Treatments can also be purchased for a patient by a third-party payer,for example, an insurance company. A third-party server system 804 cantransfer payment information 816 to the server system 802 with a patientidentifier 818 that identifies the patient. The payment information 816can include the information that completes the act of payment orindicates that payment has been made. The patient identifier 818 caninclude a name, prescription number, insurance policy number, or otheridentifier.

The server system 802 can receive the payment information 810 and thedevice identifier 812 from the medical device 10, or can receive thepayment information 816 and the patient identifier 818 from thethird-party server system 804.

The server system 802 can determine that payment has been made for anumber of treatments, for example, using the payment information 810,816. The server system 802 can also determine that patient is associatedwith the medical device, for example, using the patient identifier 818or device identifier 812 associated with the payment information 810,816. The server system 802 can use the received information and storedrecords to associate the payment with the patient to be treated with themedical device 10. The server system 802 may store records thatassociate patient identifiers 818 and device identifiers 812 withparticular patients and medical devices 10 so that payment can beapplied for the correct patient and medical device 10.

The server system 802 can also generate an authorization code 814 thatenables the medical device 10 to provide a number of treatments. Thenumber of treatments authorized can be based on the amount of paymentreceived. The server system 802 can send the authorization code 814 tothe medical device 10 through the network 806 and/or through thecellular network 808.

The authorization code 814 can be encrypted or encoded so that theauthorization code 814 enables treatments only for the particularmedical device 10 associated with a particular payment received. In oneimplementation, the authorization code 814 can be encrypted so that theunique device identifier 812 or another unique decryption key isnecessary to decrypt or decode the authorization code 814. For example,the authorization code 814 can be encrypted using a symmetric-key orasymmetric-key encryption scheme.

Using a symmetric-key or shared-key encryption system, a key may be usedas both the encryption and decryption key. The key can be stored on boththe server system 802 and the medical device 10, for example, by themanufacturer of the medical device 10. To prevent interception, the keymay not be transmitted. The medical device 10 can send a patientidentifier or a device identifier 812 unrelated to the key to identifythe medical device 10. The server system 802 can send the encrypted datato the medical device 10, which can decrypt the data with the storedkey.

Using an asymmetric-key cryptography system, for example, a public keyprivate key pair encryption system, the server system 802 can store anencryption key and the medical device 10 can store a correspondingdecryption key. The server system 802 may encrypt the authorization code814 using the encryption key and send the encrypted data to the medicaldevice 10. The medical device 10 can include a stored decryption keythat can decrypt the encrypted data. The decryption key can include thedevice identifier 812 or another key. In an implementation, theencryption key that encrypts messages for a particular medical device 10may be known only to the server system 802.

Because the server system 802 can store records associating patients,medical devices 10, and corresponding encryption keys, the system 800may not require that the decryption key be sent to the server system802. If the device identifier 812 is used to decrypt an authorizationcode 814, instead of sending the device identifier 812, the medicaldevice 10 can send another identifier, such as a patient identifier or adevice identifier unrelated to the encryption scheme. The deviceidentifier 812 can be independent of the encryption scheme so thatinterception of the device identifier does not compromise the encryptionscheme.

The medical device 10 can receive the encrypted authorization code 814through the network 806 or the cellular network 808 and can decrypt theauthorization code 814. The medical device 10 can use the authorizationcode 814 to authorize a number of treatments of the medical device 10.The authorization code 814 or information determined based on theauthorization code 814 can be stored to indicate the number oftreatments authorized. When the patient attempts to initiate treatmentwith the medical device 10, the processing device of the medical device10 can determine that authorized treatments remain for the medicaldevice 10 and initiate treatment.

The medical device 10 may also use the authorization code 814 todetermine a change in treatment. For example, an authorization code 814may indicate that treatment should be disallowed after a particularperiod of time has elapsed or if the patient does not apply a treatmentfor a period of time. The authorization code 814 may indicate that thenumber of treatments that are available each day should be changed, forexample, from one treatment each day to two treatments each day. Theauthorization code 814 may indicate that the intensity of ultrasoundproduced by the medical device 10 should be changed, for example, thatthe intensity should be reduced if the patient is healing well.

Referring to FIG. 9A, a process 900 for authorizing medical treatmentscan include actions by a medical device, a server system, and/or athird-party system. The medical device can be an ultrasonic treatmentdevice as described above.

As illustrated, the process 900 can include payment for treatment by apatient at the medical device, payment by a third-party at a remotesystem, or both sources of payment. The actions performed by the medicaldevice can be performed by one or more processing devices of the medicaldevice configured to perform those actions. The server system caninclude one or more processing devices and one or more storage devicesthat store instructions that, when executed by the one or moreprocessing devices, cause the processing devices to perform the variousfunctions of the server system described below.

A patient can attempt to initiate treatment with the medical device(902). For example, the medical device can receive user input indicatingthat a treatment should be administered by the medical device.

The medical device can determine whether treatment is authorized (903).For example, the medical device can determine whether at least onetreatment is authorized based on stored information that indicates thenumber of treatments that are authorized. The medical device can accessan authorization code that has been received, for example, and determinewhether treatment is authorized based on the accessed authorizationcode. The determination whether the attempted treatment is authorizedcan be performed in response to the attempt to initiate treatment in(902).

If the determination indicates that treatment by the medical device isauthorized, the medical device can control a treatment module to applythe treatment that the patient attempted. If the determination indicatesthat treatment is not authorized, the medical device can control thetreatment module so that the treatment attempted by the patient is notapplied. No treatment may be authorized for a medical device if, forexample, all of the previously authorized treatments have already beenused or if the medical device has not received an initial authorizationcode to enable treatments.

When treatment is not authorized for the medical device, the medicaldevice can notify the patient that payment is needed to purchaseadditional treatments (904). The example illustrated in FIG. 9A shows ascenario in which the medical device is not initially authorized toperform a treatment attempted by a patient, so additional payment andauthorization of the medical device is needed.

Payment can be received at the medical device (906). The patient canthen enter payment in one or more ways, including entering payment atthe medical device using, for example, a credit card or a debit card topurchase additional treatments. The patient may also complete payment ata location other than the medical device, and enter proof of payment atthe medical device. The patient may purchase treatments for example, ata store, at a medical office, or over the Internet. The patient may thenenter proof of payment at the medical device in the form of, forexample, a computer file, a code, or a SIM card.

The medical device can then send payment information for the paymentreceived and an identifier to the server system (908). The identifiermay be a device identifier that uniquely identifies the particularmedical device used by the patient. In other words, the deviceidentifier can identify not merely a model or type of medical device,but a single, particular medical device. The identifier may be a patientidentifier that identifies a particular patient associated with themedical device.

Treatments can also be purchased for a patient by a third-party, forexample, an insurance company. The third-party system can receive, forexample, a prescription for treatment of the patient using the medicaldevice (910). The third-party system can authorize one or moretreatments using the medical device (912). For example, the third-partysystem can authorize the treatments identified in the receivedprescription.

The third party system can send payment information and an identifier tothe server system (914). The payment information can include informationthat enables a transaction to occur, for example, an authorization tocharge an account or otherwise cause funds to be transferred, and caninclude information that indicates that payment has been performed. Theidentifier can identify the patient associated with the prescriptionthat was received in action (910). For example, the identifier caninclude a name of the patient, an insurance policy number for thepatient, a prescription identifier, or other information relating to thepatient. The identifier may also identify the medical device for thepatient.

The server system can receive payment information and an associatedidentifier from either the medical device or the third party system(916). The associated identifier can be a device identifier thatuniquely identifies the medical device. The server system can match thepayment described in the payment information with the patient and themedical device of the patient (918). The server system can store one ormore associations between a patient and the medical device configured toapply a medical treatment to the patient. For example, the server systemcan store records that associate patients with particular medicaldevices, patient identifiers, and medical device identifiers.

The server system may use one or more received identifiers to determinewhich patient and device are associated with a payment. Specifically,the server system can determine that payment has been made for thepatient for a particular number of treatments by the medical device. Thedetermination can be made based on the received information that paymenthas been made for the patient. The server system can identify themedical device associated with the patient based on the storedassociation between the patient and the medical device and, for example,based on a received device identifier that uniquely identifies themedical device. The server system may also record the determination thatpayment has been made for the user and the identification of the medicaldevice associated with the patient.

The server system can generate an authorization code that can authorizethe medical device associated with the patient to perform the purchasedtreatments (920). The authorization code can enable the number oftreatments purchased by the patient or third-party payer. Theauthorization code can be generated so that the code only enablestreatments of the particular medical device associated with the patientfor whom payment was received. For example, the authorization code maybe encoded or encrypted so that only the particular medical deviceassociated with the payment can decode or decrypt the authorizationcode. The authorization code may include or be transmitted with a uniquedevice identifier, and a medical device can be configured to enter anauthorization code only when a device identifier of the medical devicematches the device identifier received with an authorization code.

The server system can transmit the authorization code to the medicaldevice (922). The authorization code may be transmitted, for example,over a cellular communication link to the medical device that the serversystem identified as being associated with the patient.

The medical device can receive the authorization code (924). Theauthorization code may be a new authorization code that is receivedafter an initial or prior authorization code that authorized differenttreatments. The new authorization code can be received after the medicaldevice has provided an indication to the patient that more treatmentsneed to be purchased, and the new authorization code can identify anumber of additional treatments for which payment has been received.

Referring to FIG. 9B, the medical device can decrypt or decode theauthorization code (926). In one implementation, the medical device maydecrypt the authorization code using a unique device identifier ordecryption key stored on the medical device. The medical device maydetermine that an authorization code is authentic or intended for theparticular medical device that received it. The medical device maydetermine, using decrypted or decoded data, what treatments areauthorized. For example, the medical device may determine that aparticular number of treatments are authorized. The medical device mayalso determine that treatment using the medical device should bemodified in some way, for example, that two treatments are authorizedeach day instead of one treatment each day, or that the intensity ofultrasound produced should be changed.

The medical device can store authorization information (928). Forexample, the medical device can store the number of treatments that theauthorization code indicates should be authorized. The medical devicecan also store the authorization code received, the authorizationinformation extracted from the received data, and other authorizationinformation. In some instances, treatments using the medical device canbe authorized without any input or action by the patient. For example,when a third-party payer sends payment to the server system, the medicaldevice can be authorized without involvement from the patient.

The medical device can determine whether treatment is authorized (929).For example, the medical device can determine whether treatment isauthorized based on the authorization code that was accessed by themedical device. The medical device can determine whether treatmentauthorized in response to receiving user input that treatment should beprovided, in (902) or through later inputs. In the situation that thepatient has attempted treatment with the medical device in (902), andsubsequently entered payment needed to authorize treatment in (906), themedical device can proceed to apply the treatment after thedetermination is made that treatment is authorized. For example, thepayment and authorization process may occur quickly so that the patientperceives very little delay between entering payment and the initiationof treatment. In one implementation, treatment may begin automaticallywhen the patient has previously attempted to initiate treatment.Treatment may alternatively be delayed until the patient imitatestreatment again or confirms that treatment should proceed.

If the determination indicates that treatment is authorized, the medicaldevice can control a driver circuit to apply treatment (930). Forexample, the medical device may control an ultrasound transducer drivercircuit in a manner that causes one or more ultrasound transducers toproduce ultrasound with therapeutic properties. For example, the drivercircuit can be activated to drive one or more ultrasound transducers.The driver circuit may continue to drive the ultrasound transducersuntil treatment is complete. Of course, if the determination indicatesthat treatment is not authorized based on the authorization code (forexample, if the authorization code is for a different medical device, orif the treatments authorized by that code have already been expended),the medical device can control the driver circuit so that treatment isnot applied, for example, by not activating the driver circuit so thattreatment is prevented.

The driver circuit can be deactivated when treatment is finished (932).The medical device can store a record of the treatment applied (934).The medical device can also decrease the number of treatments authorizedfor the medical device (936). For example, if the medical device hadreceived an authorization code that authorized twenty treatments of themedical device, after one treatment is completed, the medical device mayupdate the number of authorized treatments to reflect that only nineteentreatments are currently authorized for the medical device.

Referring to FIG. 10, a process 1000 for storing patient information canbegin with a physician writing a prescription for a patient fortreatment using a medical device (1002). To carry out the prescribedtreatment, a medical device can be dispensed to the patient (1004). Themedical device can be authorized at the time the medical device isdispensed or at a later time.

Records for the patient and the dispensed medical device can be enteredinto a database 1014 (1006). For example, the database 1014 may store apatient record 1010 that associates a particular medical device ortreatment with a particular patient, in the example, a patient named“John Smith.” The database 1014 may also store a prescription record1012 that indicates the number of treatments that can be purchased forthe patient. The number of treatments indicated in a prescription record1012 may be authorized for application by the medical device afterpayment has been received for the prescribed treatments. For example,the treatments can be enabled after a third-party payer agrees to payfor the treatments or after the patient enters payment at the medicaldevice. The database 1014 may also store other records including recordsthat identify patient identifiers and medical device identifiers.

The information in the database can be accessed by one or more clientdevices 1018, 1020, a server system 1022, or other systems. For example,the server system 1022 may use the patient record 1010 to match paymentto a particular medical device or patient. The records stored in thedatabase 1014 may also be used to inform a third-party payer or patientthe number of treatments that should be purchased to enable a treatmentplan to be carried out.

Referring to FIG. 11, the authorized use of the medical device 10 can belimited to a particular patient and/or geographic area. In someinstances, it is desirable by an automated method to limit the use of amedical device by an unauthorized person or in an unauthorizedgeographic area, such as in a country where the device has not receivedregulatory approval or in which an unauthorized sale of the devicecircumvents the chain of distribution of the device. Other exampleswhere “geolocking” of a medical device may be desirable is where devicesare sold at different price points in different regions and it isdesirable to limit the ability of a lower priced device to be sold in ahigher priced region, where device have region specific chargers,include specific languages, or are designed for single patient use ormultiple patient use such as in some hospitals.

It is also desirable to limit a single patient use device from beingshared with other than the intended patient by, for example, resale orshared use with friends or family members, particularly where the deviceis a prescription device. The desire to limit such use is particularlyapplicable to medical devices such as the Exogen™ Ultrasound BoneHealing System sold by Smith & Nephew, Inc. that is easily transported.

To limit, and preferably prevent, the use of a medical device 10 (FIG.11) in an unauthorized geographic area, the medical device 10 includeshardware and software that determine the geographical location of themedical device 10 upon start-up and compare the determined geographicallocation to an authorized geographical location. The authorizedgeographical location can be, for example, programmed in the medicaldevice 10 during the manufacturing process. Referring to FIG. 12, themedical device 10 include a GPS receiver 1210 to determine geographicallocation, and memory 1214 to store authorized operating areas for themedical device 10. Alternatively, the medical device 10 can use cellphone networks or Wi-Fi to determine geographical location.

Referring to FIG. 13, the location of the medical device 10 is comparedto an approved area 1318 in which treatment is authorized. If thegeographical location 1320 of the device 10 is within the authorizedarea 1318, treatment begins. If the geographical location 1322 of thedevice 10 is in an unauthorized area 1324, no treatment is delivered.The device can include two-way communication, such as cellular, internetor wireless communication. To accommodate patient travel, the medicaldevice 10 can be configured to accept over-the-air-updates to theauthorized geographical location.

As illustrated in FIG. 14, for “geolocking” purposes, the medical device10 includes the GPS receiver 1412, an antenna 1430 connected to the GPSreceiver 1412 via an amplifier 1432 and a filter 1434, and a crystal1436, an integrated circuit 1438, and a regulator 1440.

Advantageously, a medical device can be designed for use within only aspecific geographical area, for example, a country or region asillustrated in FIG. 13, such that use of the device in unintendedmarkets is limited or prevented.

To limit, and preferably prevent, the use of the medical device 10 by anunauthorized person, the medical device 10 requires proof of patientidentity using, for example, a key card or token issued to the user, apassword, or physical evidence. For example, referring to FIG. 2, themedical device 10 includes hardware and software and a user interface 70implemented on the device to identify the patient using a fingerprint,retinal scan, or voice recognition. The identity of the user is comparedto the stored patient identity and treatment is only authorized when theuser is confirmed to be the patient.

As illustrated in FIG. 15, for device authorization purposes, themedical device 10 includes, for example, a fingerprint sensor 1552,control electronics such as an integrated circuit 1554, and an EPROM1556.

Advantageously, the use of a fingerprint, retinal scan, or voicerecognition ensures that the patient is at least present during thetreatment. In situations where the patient is, for example, young orelderly, the identity of a supervising individual can alternatively oradditionally be required. The fingerprint, voice or retinal scan of theauthorized user is saved into the memory of the device when the deviceis prescribed and fitted by a responsible party, for example, a doctor,pharmacist or sales representative.

Referring to FIG. 16, a method for limiting unauthorized use of themedical device 10 includes determining the geographic location of themedical device 10 and not allowing treatment to commence if thedetermined geographic location is outside an authorized geographiclocation, and/or includes determining user identity and not allowingtreatment to commence if the determined user identity does not match anauthorized identity. The medical device 10 includes means fordetermining the geographic location of the medical device 10 and meansfor determining user identity. Treatment is not allowed to commence ifeither the determined geographic location is outside an authorizedgeographic location or the determined user identity does not match anauthorized identity.

In use, the patient turns the device 10 on at step 1660, the deviceperforms a self-test of the clock and configuration at step 1662, thepatient, for example, scans his or her index finger over the fingerprintsensor 1552, and the device confirms the patient identity at step 1664.If the patient is the authorized user, the geographical location of thedevice is checked at step 1666. If the patient is not the authorizeduser, an authorization alarm is delivered at step 1668 and treatmentwill not commence. If the patient is the authorized user and the device10 is within its authorized geographical location treatment can bestarted at step 1670. If the device 10 is not within its authorizedgeographical location, an authorization alarm is delivered at step 1668and treatment will not commence.

At steps 1672, 1674 and 1676, the device 10 monitors the time of use,allowing up to 20 minutes of treatment to be delivered before endingtreatment.

The techniques described above are not limited to any particularhardware or software configuration. Rather, they may be implementedusing hardware, software, or a combination of both. The methods andprocesses described may be implemented as computer programs that areexecuted on programmable computers comprising at least one processor andat least one data storage system. The programs may be implemented in ahigh-level programming language and may also be implemented in assemblyor other lower level languages, if desired.

Any such program will typically be stored on a computer-usable storagemedium or device (e.g., CD-ROM, RAM, or magnetic disk). When read intothe processor of the computer and executed, the instructions of theprogram cause the programmable computer to carry out the variousoperations described above.

A number of implementations have been described. Nevertheless, it willbe understood that various modifications may be made. For example, thedescribed features of presentation of messages selected for a particularpatient, the collection and display of compliance information, andtreatment authorization, and medical device locking based on identity orgeographical location may be implemented for a single medical device. Inaddition, any subset of the features described can be implemented. Eachof the message presentation, compliance information collection anddisplay, treatment authorization, and medical device locking featuresmay be implemented individually, separate from the other featuresdescribed, or together in any combination.

Accordingly, other implementations are within the scope of the followingclaims.

The invention claimed is:
 1. An apparatus for treating a patient, theapparatus comprising: a treatment source configured to apply therapy todamaged tissue to facilitate healing of the damaged tissue; a memorydevice configured to store authorization data; a communication receiverconfigured to receive an update to the authorization data; and aprocessor configured to: prior to receipt of the update with thecommunication receiver, determine from the authorization data that thetreatment source is authorized for use in a first geographic area andunauthorized for use in a second geographic area, determine a firstlocation of the treatment source in response to receipt of a first userinput, permit application of therapy by the treatment source in responseto determinations that the first location is in the first geographicarea and that the treatment source is authorized for use in the firstgeographic area, determine a second location of the treatment source inresponse to receipt of a second user input, and prevent application oftherapy by the treatment source in response to determinations that thesecond location is in the second geographic area and that the treatmentsource is unauthorized for use in the second geographic area, andsubsequent to receipt of the update with the communication receiver,determine from the authorization data and the update that the treatmentsource is authorized for use in the second geographic area, determine athird location of the treatment source in response to receipt of a thirduser input, and permit application of therapy by the treatment source inresponse to determinations that the third location is in the secondgeographic area and that the treatment source is authorized for use inthe second geographic area.
 2. The apparatus of claim 1, wherein theprocessor is configured to: cause the treatment source to initiateapplication of therapy in response to determinations that the firstlocation is in the first geographic area and that the treatment sourceis authorized for use in the first geographic area; and cause thetreatment source to initiate application of therapy in response todeterminations that the third location is in the second geographic areaand that the treatment source is authorized for use in the secondgeographic area.
 3. The apparatus of claim 1, wherein the treatmentsource comprises a driver circuit configured to control application oftherapy to the damaged tissue, and the processor is configured to permitapplication of therapy by activation of the driver circuit or by failureto deactivate the driver circuit.
 4. The apparatus of claim 1, whereinthe treatment source comprises a driver circuit configured to controlapplication of therapy to the damaged tissue, and the processor isconfigured to prevent application of therapy by failure to activate thedriver circuit or by deactivation of the driver circuit.
 5. Theapparatus of claim 1, wherein the processor is configured to determineone or more of the first location, the second location, and the thirdlocation from location data from a wireless communications network. 6.The apparatus of claim 1, further comprising a GPS receiver configuredto determine a geographical location of the treatment source, theprocessor being configured to determine one or more of the firstlocation, the second location, and the third location using the GPSreceiver.
 7. The apparatus of claim 1, further comprising a userinterface configured to receive one or more of the first user input, thesecond user input, and the third user input as a selection of at leastone element of the user interface.
 8. The apparatus of claim 1, whereinthe processor is configured to, prior to receipt of the update with thecommunication receiver, activate an alarm in response to determinationsthat the second location is in the second geographic area and that thetreatment source is unauthorized for use in the second geographic area.9. The apparatus of claim 1, wherein the communication receiver isconfigured to receive the update via a wireless communications network.10. The apparatus of claim 1, further comprising a sensor, the processorbeing configured to: prior to receipt of the update with thecommunication receiver, determine from a first authentication input fromthe sensor that a first patient using the treatment source matches aprescribed patient, and further require that the first patient using thetreatment source matches the prescribed patient prior to application oftherapy by the treatment source being permitted in response todeterminations that the first location is in the first geographic areaand that the treatment source is authorized for use in the firstgeographic area, and subsequent to receipt of the update with thecommunication receiver, determine from a second authentication inputfrom the sensor that a second patient using the treatment source matchesthe prescribed patient, further require that the second patient usingthe treatment source matches the prescribed patient prior to applicationof therapy by the treatment source being permitted in response todeterminations that the third location is in the second geographic areaand that the treatment source is authorized for use in the secondgeographic area.
 11. The apparatus of claim 10, wherein the firstauthentication input comprises a fingerprint image, a retinal image, ora voice recording.
 12. The apparatus of claim 1, wherein the memorydevice is configured to store a device identifier, the authorizationdata is encrypted, and the processor is configured to decrypt theauthorization data using the device identifier.
 13. A method ofcontrolling an apparatus for treating a patient, the method comprising:determining from authorization data stored in a memory device that atreatment source is authorized for use in a first geographic area andunauthorized for use in a second geographic area; receiving a first userinput via a user interface; determining a first location of thetreatment source in response to receiving the first user input;performing first therapy to damaged tissue with the treatment source tofacilitate healing of the damaged tissue in response to determining thatthe first location is in the first geographic area and that thetreatment source is authorized for use in the first geographic area;subsequent to said performing first therapy, receiving an update to theauthorization data using a communication receiver; determining from theauthorization data and the update that the treatment source isauthorized for use in the second geographic area; receiving a seconduser input via the user interface; determining a second location of thetreatment source in response to receiving the second user input; andperforming second therapy to the damaged tissue with the treatmentsource to facilitate healing of the damaged tissue in response todetermining that the second location is in the second geographic areaand that the treatment source is authorized for use in the secondgeographic area.
 14. The method of claim 13, wherein said determiningthe first location comprises determining the first location fromlocation data from a wireless communications network.
 15. The method ofclaim 13, wherein said determining the first location comprisesdetermining the first location using a GPS receiver.
 16. The method ofclaim 13, further comprising, prior to said receiving the update,activating an alarm in response to determining that the second locationis in the second geographic area and that the treatment source isunauthorized for use in the second geographic area.
 17. The method ofclaim 13, wherein said receiving the update comprises receiving theupdate via a wireless communications network using the communicationreceiver.
 18. The method of claim 13, further comprising: receiving anauthentication input using a sensor; and determining from theauthorization data and the authentication input that the treatmentsource is authorized for use in the first geographic area.
 19. Themethod of claim 18, wherein the authentication input comprises afingerprint image, a retinal image, or a voice recording.
 20. The methodof claim 13, further comprising: storing a device identifier in thememory device; and decrypting the authorization data using the deviceidentifier.